NCT05344339

Brief Summary

There are Billroth-I, Billroth-II, Billroth-II with Braun, and Roux-en-Y reconstruction after distal gastrectomy. Hypothesis: Billroth-II modified method is non-inferior to Roux-en-Y method in terms of reducing reflux esophagitis after distal gastrectomy for gastric cancer patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
32mo left

Started Oct 2022

Longer than P75 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Oct 2022Dec 2028

First Submitted

Initial submission to the registry

April 8, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

October 8, 2022

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 1, 2025

Status Verified

December 1, 2023

Enrollment Period

5.2 years

First QC Date

April 8, 2022

Last Update Submit

December 30, 2024

Conditions

Gastric CancerDistal Gastrectomy

Keywords

Gastric CancerDistal gastrectomyReconstructionGastric adenocarcinomaRoux-en-Y

Outcome Measures

Primary Outcomes (1)

  • Reflux esophagistis

    Findings of reflux esophagitis according to Los Angeles classification via endoscopy

    on the 12th month after surgery

Secondary Outcomes (15)

  • Early complications

    30 days after surgery

  • Operative time

    Intraoperative

  • Time for making anastomosis

    Intraoperative

  • Blood loss

    Intraoperative

  • Length of post-operative hospital stay

    30 days after surgery or until mortality

  • +10 more secondary outcomes

Study Arms (2)

Billroth-II modified

EXPERIMENTAL

An opening will be made at jejunum 25 cm from Treitz's ligament. Another at greater curvature of the stomach right above transected line. A straight stapling device will be used to make isoperistaltic anastomosis at posterior wall of the stomach. After checking for bleeding, common entry hole will be closed using running suture and 3 -5 sutures to attach afferent loop to the remnant stomach

Procedure: Distal gastrectomy

Roux-en-Y

ACTIVE COMPARATOR

Jejunum will be transected 25 to 30 cm from Treitz's ligament. Marginal vessels will be transected if needed to make sure the loop will reach the stomach without tension. Isoperistaltic gastrojejunostomy will be made at posterior wall of the stomach. After checking for bleeding, common entry hole will be closed using running suture. Jejunojejunal mesenteric defect and Petersen's defect will be closed.

Procedure: Distal gastrectomy

Interventions

Distal gastrectomyPROCEDURE

Reconstruction after Distal Gastrectomy

Billroth-II modifiedRoux-en-Y

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients confirmed with gastric cancer
  • Indicated for radical distal gastrectomy (cT1 to cT4a, any N, M0; according to AJCC/UICC 8th TNM staging for gastric cancer)
  • Age from 18- to 80-year-old
  • Agreed to participate in study with written inform consent

You may not qualify if:

  • Pregnant patients
  • An American Society of Anesthesiology (ASA) score of higher than 4
  • Concurrent cancer or history of previous other cancers
  • Previous gastrectomy
  • Complications including bleeding, perforation required emergency gastrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastroenterostomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Long D Vo, MD, PhD

    University Medical Center HCMC, VN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Long D. Vo, MD PhD

CONTACT

+84918133915long.vd@umc.edu.vn

Thong Q. Dang, MD, MSc

CONTACT

+84333997861thong.dq@umc.edu.vn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open label randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2022

First Posted

April 25, 2022

Study Start

October 8, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

January 1, 2025

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)